Safety Scientist, Global Case Processing
работа от вкъщи
длъжност на пълно работно време

Safety Scientist, Global Case Processing

работа от вкъщи длъжност на пълно работно време

Описание на позицията

Unique Features:

• Leading provider of pharmaceutical services;
• One of the best in evidence-based research for both emerging and leading pharmaceutical companies;
• The first office in Bulgaria.


• Responsible for processing and evaluating (i.e. narrative writing, seriousness, causality and expectedness assessment) safety reports originating from clinical studies, literature and the post-marketing experience for client products;
• Responsible for the timely completion of safety reports for distribution to Health Authorities, clients and client’s partners;
• Responsible for the timely identification of Safety Reports and/or relevant safety information during the monitoring of the literature;
• Responsible for Quality Control of Case Processing and Literature Review deliverables;
• Ensure the quality and accuracy of data used to support any regulatory document;
• Ensure the timely and accurate completion of case processing due diligence activities;
• Ensure the timely and accurate completion of PV reconciliation activities;
• Assist in the reconciliation of clinical and safety databases;
• Prepare and follow through to completion of the Safety Database requests;
• Assist in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts;
• Assist with the preparation of relevant project-specific plans and procedures;
• Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint.


• A bachelor's Degree in a science or health-related field, pharmacy or nursing;
• Minimum of 1 year of experience in a pharmaceutical company or a service provider (e.g. CRO) with case processing responsibilities;
• Good knowledge of global and local pharmacovigilance (PV) regulations and legislation, both pre- and post-marketing required;
• Case processing experience should include drugs; Experience with safety surveillance of vaccines, biologics and medical devices is a plus but not required;
• Proficient with case processing including the use of coding dictionaries and case narrative writing, preferably within Argus
• Experience with other PV databases (e.g. ARISg)
• Experience in global and local literature review is a plus;
• Good communication, interpersonal interaction, and organizational skills;
• Ability to manage multiple client projects simultaneously with good time management skills;
• Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, and Excel);
• Must be able to speak fluent English.

What they offer:

• Competitive remuneration;
• Entirely remote work;
• Opportunities for development;

If you find our proposal interesting and want to receive more information, please, send your CV in English by applying online!

We thank all interested applicants, but we will only contact a shortlist of them! All applications are confidential.
JobTiger is a Bulgarian online job board and licensed recruiting company (License No.2547, 08.06.2018).

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